Evaluation of nanocurcumin and chlorhexidine mouthwash effect on the prostaglandin E2 biomarker concentration in gingival crevicular fluid of fixed orthodontic patients

Comparison of nanocurcumin and chlorhexidine mouthwash effect on the level of gingival crevicular fluid prostaglandin E2 of fixed orthodontic patients

A single blinded blocked randomized clinical trial on patients undergoing fixed orthodontic treatment in four groups (the group using mouthwash containing curcumin nanoparticles, the group using chlorhexidine mouthwash, the group using both nanocurcumin and chlorhexidine mouthwash at the same time, and the control group)

Orthodontics Department, Dental School, Golestan University of Medical Sciences

Inclusion criteria: Agreement to participation in the study,15 to 35 years old, Passed at least 2 mounts after fixed orthodontics treatment, Negative for hypersensitivity to Curcumin and/or chlorhexidine Exclusion criteria: The presence of any ulcer or intraoral infection, Severe gingival inflammation or periodontal pocket, Systemic disease, Pregnant and lactating mothers, Antibiotics usage in a month before the study, Fluoride therapy in the last 6 months, Tobacco usage, Corticosteroids and NSAIDs usage

nanocurcumin and chlorhexidine mouthwash application

prostaglandin E2 level in gingival crevicular fluid

Eligible subjects will be assigned to the nanocurcumin and chlorhexidine mouthwash groups, the nanocurcumin only and chlorhexidine only, and the control group using the random block method. We first create a random sequence of 11 eight-block random blocks. Random numbers were generated in R software and In each block, each letter A, B, C, D is repeated twice. ABCDACDB, CADBACBD, DACBBCAD, ABBCDACD, CADBACDB,… In the desired sequence, there will be 22 letters from each letter A, B, C, D. According to the above block, 88 envelopes will be prepared, and in each envelope, the letters A, B, C, D will be placed and will be numbered from 1 to 88. The person delivering the envelopes to the patients does not know what is inside. This intervention is a two-sided blind type where the researcher knows the type of mouthwash, but the patients do not know about it. A random sequence is produced by a statistics and methodology consultant who does not have access to patients. Patients who received the letter A in the nanocurcumin mouthwash group, patients who received the letter B in the chlorhexidine group, and patients who received the letter C in the nanocurcumin and chlorhexidine group patients who received the letter D in the control group will be placed.

In this study, only the researcher knows the type of mouthwash prescribed for each patient. Nurses and patients do not have any information about the type of mouthwash to use and only receive instructions on how to use it. The random sequence generation is done by the statistics and methodology consultant, but he does not have access to the patients and is in the category of blinded subjects.